IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL

K131662 · Siemens Healthcare Diagnostics, Inc. · JJX · Oct 10, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131662
• Device Name: IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 10, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IMMULITE® ACTH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration and reportable range of the IMMULITE ACTH assay on the IMMULITE 2000 systems

Device Story

The IMMULITE 2000 ACTH Calibration Verification Material (CVM) is a set of four lyophilized vials containing processed bovine protein matrix with preservatives. Levels 2, 3, and 4 contain varying concentrations of ACTH. The device is used in clinical laboratory settings by laboratory professionals to verify the calibration and reportable range of the IMMULITE ACTH assay on IMMULITE 2000 systems. The user processes the CVM samples on the analyzer; the system generates dose values based on the reference calibrator curve. The healthcare provider compares these recovered values against assigned target ranges to ensure the assay's accuracy and performance within the reportable range (5-1250 pg/mL). This verification process helps ensure the reliability of patient ACTH test results, supporting clinical decision-making for conditions related to ACTH levels.

Clinical Evidence

Bench testing only. Stability was validated over 2 years at -20°C. Value assignment and performance were verified using 27 replicates across 8 systems and 5 reagent lots. Acceptance criteria required dose values to fall within ±10% of assigned dose or within 2SD of the target value. No clinical data (human trials) were required or presented.

Technological Characteristics

Lyophilized bovine protein matrix with preservatives. Four-level material (LACCVM1-4). Traceable to internal gravimetrically prepared ACTH antigen stock. Storage at -20°C. Designed for use on IMMULITE 2000 systems. No software or electronic components; purely a chemical quality control material.

Indications for Use

Indicated for in vitro diagnostic use to verify calibration and reportable range of the IMMULITE ACTH assay on IMMULITE 2000 systems. For prescription use only.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k131662

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.